Phase III Study of Monolaurin Cream Therapy for Patients With Congenital Ichthyosis
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|ClinicalTrials.gov Identifier: NCT00004690|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
OBJECTIVES: I. Compare the safety and efficacy of monolaurin cream versus a placebo vehicle cream in suppressing the signs of nonbullous congenital ichthyosiform erythroderma.
II. Assess the incidence of posttreatment rebound or recrudescence in patients with congenital ichthyosis.
III. Evaluate the long term safety of monolaurin cream with whole body application in these patients.
|Condition or disease||Intervention/treatment||Phase|
|Ichthyosis||Drug: monolaurin cream||Phase 3|
PROTOCOL OUTLINE: This is a three month, randomized, double blind, placebo controlled study followed by a nine month, open label, rollover study.
Patients are treated either with a placebo vehicle cream or the study cream, monolaurin (15% glyceryl monolaurate), for 3 months followed by a four week break. Medications are applied uniformly twice daily (morning and at least 1 hour before bedtime). After this blinded portion of the study, all patients are administered monolaurin cream for 9 months.
Patients are followed for 4 weeks after the last cream application.
Completion date provided represents the completion date of the grant per OOPD records
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Study Start Date :||September 1996|
|Estimated Study Completion Date :||September 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004690
|Study Chair:||Carl R. Thornfeldt||Cellegy Pharmaceuticals|